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Clinical Trial
. 2016 Oct;196(4):1096-104.
doi: 10.1016/j.juro.2016.05.113. Epub 2016 Jun 9.

Final Results of a Phase I/II Multicenter Trial of WST11 Vascular Targeted Photodynamic Therapy for Hemi-Ablation of the Prostate in Men with Unilateral Low Risk Prostate Cancer Performed in the United States

Samir S Taneja  1 , James Bennett  2 , Jonathan Coleman  3 , Robert Grubb  4 , Gerald Andriole  4 , Robert E Reiter  5 , Leonard Marks  5 , Abdel-Rahmene Azzouzi  6 , Mark Emberton  7
Affiliations
Clinical Trial

Final Results of a Phase I/II Multicenter Trial of WST11 Vascular Targeted Photodynamic Therapy for Hemi-Ablation of the Prostate in Men with Unilateral Low Risk Prostate Cancer Performed in the United States

Samir S Taneja et al. J Urol. 2016 Oct.

Abstract

Purpose: Vascular targeted photodynamic therapy with WST11 (TOOKAD® Soluble) is a form of tissue ablation that may be used therapeutically for localized prostate cancer. To study dosing parameters and associated treatment effects we performed a prospective, multicenter, phase I/II trial of WST11 vascular targeted photodynamic therapy of prostate cancer.

Materials and methods: A total of 30 men with unilateral, low volume, Gleason 3 + 3 prostate cancer were enrolled at 5 centers after local institutional review board approval. Light energy, fiber number and WST11 dose were escalated to identify optimal dosing parameters for vascular targeted photodynamic therapy hemi-ablation. Men were treated with photodynamic therapy and evaluated by posttreatment magnetic resonance imaging and biopsy. Prostate specific antigen, light dose index (defined as fiber length/desired treatment volume), toxicity and quality of life parameters were recorded.

Results: After dose escalation 21 men received optimized dosing of 4 mg/kg WST11 at 200 J energy. On posttreatment biopsy residual prostate cancer was found in the treated lobe in 10 men, the untreated lobe in 4 and both lobes in 1. At a light dose index of 1 or greater with optimal dosing in 15 men 73.3% had a negative biopsy in the treated lobe. Six men undergoing retreatment with the optimal dose and a light dose index of 1 or greater had a negative posttreatment biopsy. Minimal effects were observed on urinary and sexual function, and overall quality of life.

Conclusions: Hemi-ablation of the prostate with WST11 vascular targeted photodynamic therapy was well tolerated and resulted in a negative biopsy in the treated lobe in the majority of men. Dosing parameters and the light dose index appear related to tissue response as determined by magnetic resonance imaging and biopsy. These parameters may serve as the basis for further prospective studies.

Keywords: WST11 compound; ablation techniques; laser therapy; photochemotherapy; prostatic neoplasms.

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Figures

Figure 1a
Figure 1a
Relationship between Energy Delivery and Prostate Necrosis at Day 7.
Figure 1b
Figure 1b
Relationship between LDI and Prostate Necrosis at Day 7
Figure 2
Figure 2
PSA kinetics following VTP
Figure 3a
Figure 3a
Evolution of IPSS Sum of Scores for Questions 1 to 7 following VTP
Figure 3b
Figure 3b
Evolution of 5-IIEF Sum of Scores following VTP
Figure 4
Figure 4
Evolution of FACT-P total score following VTP
See this image and copyright information in PMC

Comment in

  • Editorial Comment.
    Stief CG. Stief CG. J Urol. 2016 Oct;196(4):1103-4. doi: 10.1016/j.juro.2016.05.116. Epub 2016 Jun 23. J Urol. 2016. PMID: 27344527 No abstract available.
  • Editorial Comment.
    Schostak M. Schostak M. J Urol. 2016 Oct;196(4):1103. doi: 10.1016/j.juro.2016.05.115. Epub 2016 Jun 23. J Urol. 2016. PMID: 27344528 No abstract available.
  • Reply by Authors.
    [No authors listed] [No authors listed] J Urol. 2016 Oct;196(4):1104. doi: 10.1016/j.juro.2016.05.133. Epub 2016 Aug 25. J Urol. 2016. PMID: 27567059 No abstract available.

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